Screening Magnetic Resonance Imaging of the Brain in Patients With Breast Cancer

Breast Cancer Clinical Trial

Official title:

Screening Magnetic Resonance Imaging of the Brain in Patients With Metastatic Breast Cancer Managed With First/Second Line Chemotherapy or Inflammatory Breast Cancer Managed With Definitive Intent: A Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04030507
• Other study ID #: 19-066
• Status: Recruiting
• Phase: N/A
• Start date: July 26, 2019
• Est. completion date: February 2026

Study information

• Verified date: September 2023
• Source: Dana-Farber Cancer Institute
• Contact: Ayal Aizer, MD, MHS
• Phone: 617-732-7560
• Email: aaaizer[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research study is studying the usefulness of magnetic resonance imaging (MRI) to screen for brain metastases (spread of the breast cancer to the brain).

Description:

This research study is a Phase II clinical trial. Phase II clinical trials examine the safety and effectiveness of an investigational intervention, in this case magnetic resonance imaging (MRI) of the brain, to learn whether it is helpful in managing a specific disease.

In this research study, the investigators are utilizing screening MRIs of the brain to evaluate breast cancer patients for metastases to the brain. The investigators hope to understand whether screening MRIs of the brain can be implemented into the standard of care to earlier detect brain metastases in a population where screening MRIs of the brain are not currently recommended or systematically performed.

This trial will contain 4 cohorts:

1. Those with triple negative breast cancer (TNBC) will undergo screening MRI of the brain as part of a single arm, non-comparative study

2+3. Those with hormone receptor positive/(human epidermal growth factor receptor 2 (HER2) negative (HR+/HER2-) and HER2 positive (HER2+) subtypes will be randomized to receipt of screening MRI of the brain or no screening MRI of the brain to definitively test the value of MRI screening.

4. Patients with inflammatory breast cancer being treated with curative intent will undergo screening MRI of the brain as part of a single arm, non-comparative study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 214
• Est. completion date: February 2026
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants must have histologically or cytologically confirmed breast cancer with pathologic assessment of estrogen receptor (ER), progesterone receptor (PR), and (human epidermal growth factor receptor 2 (HER2) status. If subtype has changed over the course of a patient's disease, the treating clinician and/or study PI is responsible for selecting the subtype that most likely reflects the preponderance of oncologic disease at the time of enrollment.

• Participants must have radiographic evidence of extracranial, distant metastases or unresectable, locally recurrent breast cancer and be initiating (within 8 weeks of registration) first-line or second-line chemotherapy for their metastatic/recurrent disease OR inflammatory breast cancer being managed with curative intent within six months of diagnosis.

• Participants must be age 18 years or older.

• Participants must have a life expectancy of greater than 12 weeks.

• Participants must be willing to undergo study procedures.

• The effects of gadolinium / other magnetic resonance imaging (MRI)-based contrast agents on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.

• Participants must possess the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Participants who have a contraindication to MRI (e.g. noncompatible implanted metallic device for which MRI is absolutely contraindicated).

• Participants who have chronic kidney disease stage IV-V or end stage renal disease.

• Participants with a history of anaphylactic reactions to gadolinium.

• Pregnant women are excluded from this study because gadolinium-based agents have not been proven to be safe to administer to a developing fetus. Similarly, breastfeeding women will be excluded from this study.

• Patients with a prior diagnosis of brain metastases

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• HER2-positive Breast Cancer
• Hormone Receptor Positive Malignant Neoplasm of Breast
• Inflammatory Breast Cancer
• Metastatic Breast Cancer
• Neoplasms
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Device:
• MRI
MRI (which stands for magnetic resonance imaging) provide imaging of the brain which help look for brain metastases (spread of the breast cancer to the brain).

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Conquer Cancer Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurologic Quality of Life at 12 Months using the MD Anderson Symptom Inventory - Brain Tumor Module	For patients with HR+/HER2- or HER2+ metastatic breast cancer	12 Months
Primary	Incidence of Symptomatic Brain Metastases	For patients with triple negative metastatic breast cancer	Through study completion, an average of 1 year
Primary	Incidence of Brain Metastases	For patients with inflammatory breast cancer managed with curative intent	Through study completion, an average of 1 year
Secondary	Number of brain metastases		Through study completion, an average of 1 year
Secondary	Size of brain metastases		Through study completion, an average of 1 year
Secondary	Development of metastases in the brainstem as seen on magnetic resonance imaging of the brain		Through study completion, an average of 1 year
Secondary	Development of leptomeningeal carcinomatosis as seen on magnetic resonance imaging of the brain		Through study completion, an average of 1 year
Secondary	Radiographic appearance of brain metastases		Through study completion, an average of 1 year
Secondary	Development of symptomatic brain metastases based on review of medical notes / history		Through study completion, an average of 1 year
Secondary	Neurologic death		Through study completion, an average of 1 year
Secondary	All-cause mortality		Through study completion, an average of 1 year
Secondary	Development of seizures based on review of medical notes / history		Through study completion, an average of 1 year
Secondary	Receipt of whole brain radiation due to brain metastases		Through study completion, an average of 1 year
Secondary	Receipt of neurosurgical resection due to brain metastases		Through study completion, an average of 1 year
Secondary	Quality of life assessment via EuroQol Group 5D Instrument		Through study completion, an average of 1 year
Secondary	Neurocognitive function using the Hopkins Verbal Learning Test Instrument		Through study completion, an average of 1 year
Secondary	Neurocognitive function using the Trail Making Test Instrument		Through study completion, an average of 1 year
Secondary	Neurocognitive function using the Controlled Oral Word Association Test		Through study completion, an average of 1 year
Secondary	Neurocognitive function using the Mini-Mental Status Exam Instrument		Through study completion, an average of 1 year